NCT03020693

Brief Summary

This study evaluates the effectiveness of an electrostimulation treatment with TENS using a needle and a surface electrode combined with an exercise program to fasciitis plantar. Half participants will receive invasive electrostimulation (TENS using a needle) and exercises while the other half will receive electrostimulation placebo and exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

December 28, 2016

Last Update Submit

February 11, 2019

Conditions

Fasciitis, Plantar

Keywords

electrostimulationexercise program

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.

    It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.

    6 weeks

Secondary Outcomes (4)

  • Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.

    6 weeks

  • Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.

    6 weeks

  • Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.

    6 weeks

  • Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.

    6 weeks

Study Arms (2)

Invasive electrostimulation combined with exercises.

EXPERIMENTAL

Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.

Procedure: Invasive electrostimulation combined with exercises

Placebo electrostimulation and exercises.

ACTIVE COMPARATOR

Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.

Procedure: Placebo electrostimulation and exercises

Interventions

Invasive electrostimulation combined with exercisesPROCEDURE

Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.

Also known as: dry needling with TENS
Invasive electrostimulation combined with exercises.
Placebo electrostimulation and exercisesPROCEDURE

First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.

Also known as: Non-invasive electrostimulation combined with exercises
Placebo electrostimulation and exercises.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of plantar fasciitis
  • Age equal or superior to 18 years old.
  • VAS minimum of 2 points int the first steps after a prolonged decreasing period.
  • Having an evolution of a month or more of pain.
  • Not having received acupuncture or dry needling as treatment.

You may not qualify if:

  • Peripheral Neuropathies.
  • Tarsus tunnel syndrome.
  • Rheumatic diseases.
  • Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.
  • Clotting disorders such as thrombosis or thrombophlebitis.
  • Fractures, infections and/ or tumor processes.
  • Have been treated for plantar fasciitis in the las 4 weeks.
  • Previous surgery in the foot
  • Pregnancy.
  • Communication Disorders.
  • Holders of pacemakers or electrostimulators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Hospital Ramón y Cajal

Madrid, 28834, Spain

Location

Related Publications (2)

  • Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.

    PMID: 27526703BACKGROUND

  • Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran. 2016 Jul 23;30:401. eCollection 2016.

    PMID: 27683642RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

ExerciseDry NeedlingTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesElectric Stimulation TherapyRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 13, 2017

Study Start

January 27, 2017

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

February 15, 2019

Record last verified: 2018-02

Locations

ES(1)